Remote Monitoring

GUDID 00887517206176

NV RM Needle Electrodes, IOM EMG Module

Nuvasive, Inc.

Neurophysiologic monitoring system
Primary Device ID00887517206176
NIH Device Record Key55ea4009-bf92-46e5-a50c-1191d3508916
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemote Monitoring
Version Model Number8010201
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517206176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-25
Device Publish Date2019-11-15

On-Brand Devices [Remote Monitoring]

00887517213402Multimodality IOM Kit
00887517212993RLN IOM Kit
00887517212986EMG IOM Kit
00887517212979MEP IOM Kit
00887517212962SSEP IOM Kit
00887517210838NV RM Needle Module, NVM5 IOM MEP/EMG
00887517210821NV RM Needle Module, NVM5 IOM EMG
00887517206695NV RM Module, NVM5 IOM SSEP
00887517206688NV RM Surface Module, NVM5 IOM MEP/EMG
00887517206671NV RM Surface Module, NVM5 IOM EMG
00887517206183NV RM Surface Electrodes, IOM EMG Module
00887517206176NV RM Needle Electrodes, IOM EMG Module

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